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Irene Petersen,1,2 Catherine A Welch,3 Irwin Nazareth,1 Kate Walters,1 Louise Marston,1 Richard W Morris,4 James R Carpenter,5,6 Tim P Morris,5 Tra My Pham1 1Department of Primary Care and Population Health, University College London, London NW3 2PF, UK; 2Department of Clinical Epidemiology, Aarhus University, 8200 Aarhus N, Denmark; 3Department of Health Sciences, University of Leicester, Leicester LE1 7RH, UK; 4Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol BS8 2PS, UK; 5MRC Clinical Trials Unit at UCL, London WC1V 6LJ, UK; 6Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London WC1E 7HT, UK Background: Clinical databases are increasingly used for health research; many of them capture information on common health indicators including height, weight, blood pressure, cholesterol level, smoking status, and alcohol consumption. However, these are often not recorded on a regular basis; missing data are ubiquitous. We described the recording of health indicators in UK primary care and evaluated key implications for handling missing data.Methods: We examined the recording of health indicators in The Health Improvement Network (THIN) UK primary care database over time, by demographic variables (age and sex) and chronic diseases (diabetes, myocardial infarction, and stroke). Using weight as an example, we fitted linear and logistic regression models to examine the associations of weight measurements and the probability of having weight recorded with individuals’ demographic characteristics and chronic diseases.Results: In total, 6,345,851 individuals aged 18–99 years contributed data to THIN between 2000 and 2015. Women aged 18–65 years were more likely than men of the same age to have health indicators recorded; this gap narrowed after age 65. About 60–80% of individuals had their height, weight, blood pressure, smoking status, and alcohol consumption recorded during the first year of registration. In the years following registration, these proportions fell to 10%–40%. Individuals with chronic diseases were more likely to have health indicators recorded, particularly after the introduction of a General Practitioner incentive scheme. Individuals’ demographic characteristics and chronic diseases were associated with both observed weight measurements and missingness in weight.Conclusion: Missing data in common health indicators will affect statistical analysis in health research studies. A single analysis of primary care data using the available information alone may be misleading. Multiple imputation of missing values accounting for demographic characteristics and disease status is recommended but should be considered and implemented carefully. Sensitivity analysis exploring alternative assumptions for missing data should also be evaluated. Keywords: primary care, EHRs, recording, QOF, multiple imputation, statistics, epidemiology, research methods, data analysis

Manuj Sharma,1 Irwin Nazareth,1 Irene Petersen1,2 1Department of Primary Care and Population Health, University College London, London, UK; 2Department of Clinical Epidemiology, Aarhus University, Aarhus, Denmark Abstract: Observational studies which evaluate effectiveness are often viewed with skepticism owing to the fact that patients are not randomized to treatment, meaning that results are more prone to bias. Therefore, randomized controlled trials remain the gold standard for evaluating treatment effectiveness. However, it is not always possible to conduct randomized trials. This may be due to financial constraints, for example, in identifying funding for a randomized trial for medicines that have already gained market authorization. There can also be challenges with recruitment, for example, of people with rare conditions or in hard-to-reach population subgroups. This is why observational studies are still needed. In this manuscript, we discuss how researchers can mitigate the risk of bias in the most common type of observational study design for evaluation of treatment effectiveness, the cohort study. We outline some key issues that warrant careful consideration at the outset when the question is being developed and the cohort study is being designed. We focus our discussion on the importance of deciding when to start follow-up in a study, choosing a comparator, managing confounding and measuring outcomes. We also illustrate the application of these considerations in a more detailed case study based on an examination of comparative effectiveness of two antidiabetic treatments using data collected during routine clinical practice. Keywords: epidemiology, therapeutics, diabetes mellitus, public health, effectiveness

L Fardet,1–3 I Nazareth,1 I Petersen1 1Department of Primary Care and Population Health, University College London, UK; 2Department of Dermatology, Henri Mondor Hospital AP-HP, Créteil, France; 3Equipe d’Accueil 7379 EpiDermE, Université Paris Est Créteil, Créteil, France Background: Hydroxychloroquine and chloroquine may reduce the risk of cancer as they inhibit autophagy, in particular, in people with connective tissue diseases.Methods: The hazard ratios of cancers, metastases, and death were assessed in adults with connective tissue diseases prescribed hydroxychloroquine/chloroquine for at least 1 year in comparison with unexposed individuals with the same underlying conditions. A competing risk survival regression analysis was performed. Data were extracted from the Health Improvement Network UK primary care database.Results: Eight thousand nine hundred and ninety-nine individuals exposed to hydroxychloroquine (98.6%) or chloroquine (1.4%) and 24,118 unexposed individuals were included in the study (median age: 56 [45–66] years, women: 76.8%). When compared to the unexposed group, individuals exposed to hydroxychloroquine/chloroquine were not at lower risk of non-skin cancers (adjusted sub-distribution hazard ratio [sHR]: 1.04 [0.92–1.18], p=0.54), hematological malignancies (adjusted sHR: 1.00 [0.73–1.38], p=0.99), or skin cancers (adjusted sHR: 0.92 [0.78–1.07], p=0.26). The risk of metastasis was not significantly different between the two groups. However, it was significantly lower during the exposure period when compared with the unexposed (adjusted sHR: 0.64 [0.44–0.95] for the overall population and 0.61 [0.38–1.00] for those diagnosed with incident cancers). The risk of death was also significantly lower in those exposed to hydroxychloroquine/chloroquine (adjusted HR: 0.90 [0.81–1.00] in the overall population and 0.78 [0.64–0.96] in those diagnosed with incident cancer).Conclusion: Individuals on long-term exposure to hydroxychloroquine/chloroquine are not at lower risk of cancer. However, hydroxychloroquine/chloroquine may lower the risk of metastatic cancer and death. Keywords: antimalarial drugs, cancer, death, connective tissue diseases

Irene Petersen,1,2 Shuk-Li Collings,1,3 Rachel L McCrea,1 Irwin Nazareth,1 David P Osborn,4 Phil J Cowen,5 Cormac J Sammon1 1Department of Primary Care and Population Health, University College London, London, UK; 2Department of Clinical Epidemiology, Aarhus University, Aarhus N, Denmark; 3OXON Epidemiology, London, UK; 4Division of Psychiatry, University College London, London, UK; 5University Department of Psychiatry, Warneford Hospital, Oxford, UK Objective: The aim of this study was to examine the prevalence of major congenital malformations associated with antiepileptic drug (AED) treatment in pregnancy.Patients and methods: Using data from The Health Improvement Network, we identified women who have given live birth and their offspring. Four subgroups were selected based on the AED treatment in early pregnancy, valproate, carbamazepine, lamotrigine and women not receiving AED treatment. We compared the prevalence of major congenital malformations within children of these four groups and estimated prevalence ratios (PRs) using Poisson regression adjusted for maternal age, sex of child, quintiles of Townsend deprivation score and indication for treatment.Results: In total, 240,071 women were included in the study. A total of 229 women were prescribed valproate in pregnancy, 357 were prescribed lamotrigine and 334 were prescribed carbamazepine and 239,151 women were not prescribed AEDs. Fifteen out of 229 (6.6%) women prescribed valproate gave birth to a child with a major congenital malformation. The figures for lamotrigine, carbamazepine and women not prescribed AEDs were 2.7%, 3.3% and 2.2%, respectively. The prevalence of major congenital malformation was similar for women prescribed lamotrigine or carbamazepine compared to women with no AED treatment in pregnancy. For women prescribed valproate in polytherapy, the prevalence was fourfold higher. After adjustments, the effect of estimates attenuated, but the prevalence remained two- to threefold higher in women prescribed valproate.Conclusion: The results of our study suggest that lamotrigine and carbamazepine are safer treatment options than valproate in pregnancy and should be considered as alternative treatment options for women of childbearing potential and in pregnancy. Keywords: pregnancy, valproate, lamotrigine, carbamazepine, adverse drug effects

Manuj Sharma,1 Irene Petersen,1,2 Irwin Nazareth,1 Sonia J Coton,1 1Department of Primary Care and Population Health, University College London, London, UK; 2Department of Clinical Epidemiology, Aarhus University, Aarhus, Denmark Background: Research into diabetes mellitus (DM) often requires a reproducible method for identifying and distinguishing individuals with type 1 DM (T1DM) and type 2 DM (T2DM). Objectives: To develop a method to identify individuals with T1DM and T2DM using UK primary care electronic health records. Methods: Using data from The Health Improvement Network primary care database, we developed a two-step algorithm. The first algorithm step identified individuals with potential T1DM or T2DM based on diagnostic records, treatment, and clinical test results. We excluded individuals with records for rarer DM subtypes only. For individuals to be considered diabetic, they needed to have at least two records indicative of DM; one of which was required to be a diagnostic record. We then classified individuals with T1DM and T2DM using the second algorithm step. A combination of diagnostic codes, medication prescribed, age at diagnosis, and whether the case was incident or prevalent were used in this process. We internally validated this classification algorithm through comparison against an independent clinical examination of The Health Improvement Network electronic health records for a random sample of 500 DM individuals. Results: Out of 9,161,866 individuals aged 0–99 years from 2000 to 2014, we classified 37,693 individuals with T1DM and 418,433 with T2DM, while 1,792 individuals remained unclassified. A small proportion were classified with some uncertainty (1,155 [3.1%] of all individuals with T1DM and 6,139 [1.5%] with T2DM) due to unclear health records. During validation, manual assignment of DM type based on clinical assessment of the entire electronic record and algorithmic assignment led to equivalent classification in all instances. Conclusion: The majority of individuals with T1DM and T2DM can be readily identified from UK primary care electronic health records. Our approach can be adapted for use in other health care settings. Keywords: diabetes and endocrinology, epidemiology, public health, databases, algorithm

Aidan G O’Keeffe,1 Irwin Nazareth,2 Irene Petersen2 1Department of Statistical Science, 2Department of Primary Care and Population Health, University College London, London, UK Background: Statins are widely prescribed for the primary prevention of cardiovascular disease. Guidelines exist for statin prescriptions, but there is little recent analysis concerning prescription trends over time and how these vary with respect to demographic variables.Methods and results: Using The Health Improvement Network primary care database, statin therapy initiation and statin prescription prevalence rates were calculated using data from 7,027,711 individuals across the UK for the years 1995 to 2013, overall and stratified by sex, age group, and socioeconomic deprivation level (Townsend score). Statin therapy initiation rates rose sharply from 1995 (0.51 per 1,000 person-years) up to 2006 (19.83 per 1,000 person-years) and thereafter declined (10.76 per 1,000 person-years in 2013). Males had higher initiation rates than females and individuals aged 60–85 years had higher initiation rates than younger or more elderly age groups. Initiation rates were slightly higher as social deprivation level increased, after accounting for age and sex. Prescription prevalence increased sharply from 1995 (2.36 per 1,000 person-years) to 2013 (128.03 per 1,000 person-years) with males generally having a higher prevalence rate, over time, than females. Prevalence rates over time were generally higher for older age groups but were similar with respect to social deprivation level.Conclusion: The uptake of statins within UK primary care has increased greatly over time with statins being more commonly prescribed to older patients in general and, in recent years, males appear to have been prescribed statins at higher rates than females. After accounting for age and sex, the statin therapy initiation rate increases with the level of social deprivation. Keywords: cardiovascular disease, primary prevention, statin therapy, time trend, United Kingdom

Objective: Nearly half of care home residents with advanced dementia have clinically significant agitation. Little is known about costs associated with these symptoms toward the end of life. We calculated monetary costs associated with agitation from UK National Health Service, personal social services, and societal perspectives.Design: Prospective cohort study.Setting: Thirteen nursing homes in London and the southeast of England.Participants: Seventy-nine people with advanced dementia (Functional Assessment Staging Tool grade 6e and above) residing in nursing homes, and thirty-five of their informal carers.Measurements: Data collected at study entry and monthly for up to 9 months, extrapolated for expression per annum. Agitation was assessed using the Cohen-Mansfield Agitation Inventory (CMAI). Health and social care costs of residing in care homes, and costs of contacts with health and social care services were calculated from national unit costs; for a societal perspective, costs of providing informal care were estimated using the resource utilization in dementia (RUD)-Lite scale.Results: After adjustment, health and social care costs, and costs of providing informal care varied significantly by level of agitation as death approached, from £23,000 over a 1-year period with no agitation symptoms (CMAI agitation score 0-10) to £45,000 at the most severe level (CMAI agitation score >100). On average, agitation accounted for 30% of health and social care costs. Informal care costs were substantial, constituting 29% of total costs.Conclusions: With the increasing prevalence of dementia, costs of care will impact on healthcare and social services systems, as well as informal carers. Agitation is a key driver of these costs in people with advanced dementia presenting complex challenges for symptom management, service planners, and providers. [ABSTRACT FROM AUTHOR]

Background: Hydroxychloroquine and chloroquine may reduce the risk of cancer as they inhibit autophagy, in particular, in people with connective tissue diseases. Methods: The hazard ratios of cancers, metastases, and death were assessed in adults with connective tissue diseases prescribed hydroxychloroquine/chloroquine for at least 1 year in comparison with unexposed individuals with the same underlying conditions. A competing risk survival regression analysis was performed. Data were extracted from the Health Improvement Network UK primary care database. Results: Eight thousand nine hundred and ninety-nine individuals exposed to hydroxychloroquine (98.6%) or chloroquine (1.4%) and 24,118 unexposed individuals were included in the study (median age: 56 [45-66] years, women: 76.8%). When compared to the unexposed group, individuals exposed to hydroxychloroquine/chloroquine were not at lower risk of non-skin cancers (adjusted sub-distribution hazard ratio [sHR]: 1.04 [0.92-1.18], p=0.54), hematological malignancies (adjusted sHR: 1.00 [0.73-1.38], p=0.99), or skin cancers (adjusted sHR: 0.92 [0.78-1.07], p=0.26). The risk of metastasis was not significantly different between the two groups. However, it was significantly lower during the exposure period when compared with the unexposed (adjusted sHR: 0.64 [0.44-0.95] for the overall population and 0.61 [0.38-1.00] for those diagnosed with incident cancers). The risk of death was also significantly lower in those exposed to hydroxychloroquine/chloroquine (adjusted HR: 0.90 [0.81-1.00] in the overall population and 0.78 [0.64-0.96] in those diagnosed with incident cancer). Conclusion: Individuals on long-term exposure to hydroxychloroquine/chloroquine are not at lower risk of cancer. However, hydroxychloroquine/chloroquine may lower the risk of metastatic cancer and death. [ABSTRACT FROM AUTHOR]

Objectives: To estimate the 'real-world effectiveness of statins for primary prevention of cardiovascular disease (CVD) and for lipid modification in people with severe mental illnesses (SMI), including schizophrenia and bipolar disorder. Design: Series of staggered cohorts. We estimated the effect of statin prescribing on CVD outcomes using a multivariable Poisson regression model or linear regression for cholesterol outcomes. Setting: 587 general practice (GP) surgeries across the UK reporting data to The Health Improvement Network. Participants: All permanently registered GP patients aged 40-84 years between 2002 and 2012 who had a diagnosis of SMI. Exclusion criteria were pre-existing CVD, statin-contraindicating conditions or a statin prescription within the 24 months prior to the study start. Exposure: One or more statin prescriptions during a 24-month 'baseline' period (vs no statin prescription during the same period). Main outcome measures: The primary outcome was combined first myocardial infarction and stroke. All-cause mortality and total cholesterol concentration were secondary outcomes. Results: We identified 2944 statin users and 42 886 statin non-users across the staggered cohorts. Statin prescribing was not associated with significant reduction in CVD events (incident rate ratio 0.89; 95% CI 0.68 to 1.15) or all-cause mortality (0.89; 95% CI 0.78 to 1.02). Statin prescribing was, however, associated with statistically significant reductions in total cholesterol of 1.2 mmol/L (95% CI 1.1 to 1.3) for up to 2 years after adjusting for differences in baseline characteristics. On average, total cholesterol decreased from 6.3 to 4.6 in statin users and 5.4 to 5.3 mmol/L in non-users. Conclusions: We found that statin prescribing to people with SMI in UK primary care was effective for lipid modification but not CVD events. The latter finding may reflect insufficient power to detect a smaller effect size than that observed in randomised controlled trials of statins in people without SMI. [ABSTRACT FROM AUTHOR]

Background: Existing dementia risk scores require collection of additional data from patients, limiting their use in practice. Routinely collected healthcare data have the potential to assess dementia risk without the need to collect further information. Our objective was to develop and validate a 5-year dementia risk score derived from primary healthcare data.Methods: We used data from general practices in The Health Improvement Network (THIN) database from across the UK, randomly selecting 377 practices for a development cohort and identifying 930,395 patients aged 60-95 years without a recording of dementia, cognitive impairment or memory symptoms at baseline. We developed risk algorithm models for two age groups (60-79 and 80-95 years). An external validation was conducted by validating the model on a separate cohort of 264,224 patients from 95 randomly chosen THIN practices that did not contribute to the development cohort. Our main outcome was 5-year risk of first recorded dementia diagnosis. Potential predictors included sociodemographic, cardiovascular, lifestyle and mental health variables.Results: Dementia incidence was 1.88 (95% CI, 1.83-1.93) and 16.53 (95% CI, 16.15-16.92) per 1000 PYAR for those aged 60-79 (n = 6017) and 80-95 years (n = 7104), respectively. Predictors for those aged 60-79 included age, sex, social deprivation, smoking, BMI, heavy alcohol use, anti-hypertensive drugs, diabetes, stroke/TIA, atrial fibrillation, aspirin, depression. The discrimination and calibration of the risk algorithm were good for the 60-79 years model; D statistic 2.03 (95% CI, 1.95-2.11), C index 0.84 (95% CI, 0.81-0.87), and calibration slope 0.98 (95% CI, 0.93-1.02). The algorithm had a high negative predictive value, but lower positive predictive value at most risk thresholds. Discrimination and calibration were poor for the 80-95 years model.Conclusions: Routinely collected data predicts 5-year risk of recorded diagnosis of dementia for those aged 60-79, but not those aged 80+. This algorithm can identify higher risk populations for dementia in primary care. The risk score has a high negative predictive value and may be most helpful in 'ruling out' those at very low risk from further testing or intensive preventative activities. [ABSTRACT FROM AUTHOR]

Objective: To quantify the effect of strategies to improve retention in randomised trials. Design: Systematic review and meta-analysis. Data sources: Sources searched: MEDLINE, EMBASE, PsycINFO, DARE, CENTRAL, CINAHL, C2-SPECTR, ERIC, PreMEDLINE, Cochrane Methodology Register, Current Controlled Trials metaRegister, WHO trials platform, Society for Clinical Trials (SCT) conference proceedings and a survey of all UK clinical trial research units. Review methods: Included trials were randomised evaluations of strategies to improve retention embedded within host randomised trials. The primary outcome was retention of trial participants. Data from trials were pooled using the fixed-effect model. Subgroup analyses were used to explore the heterogeneity and to determine whether there were any differences in effect by the type of strategy. Results: 38 retention trials were identified. Six broad types of strategies were evaluated. Strategies that increased postal questionnaire responses were: adding, that is, giving a monetary incentive (RR 1.18; 95% CI 1.09 to 1.28) and higher valued incentives (RR 1.12; 95% CI 1.04 to 1.22). Offering a monetary incentive, that is, an incentive given on receipt of a completed questionnaire, also increased electronic questionnaire response (RR 1.25; 95% CI 1.14 to 1.38). The evidence for shorter questionnaires (RR 1.04; 95% CI 1.00 to 1.08) and questionnaires relevant to the disease/condition (RR 1.07; 95% CI 1.01 to 1.14) is less clear. On the basis of the results of single trials, the following strategies appeared effective at increasing questionnaire response: recorded delivery of questionnaires (RR 2.08; 95% CI 1.11 to 3.87); a 'package' of postal communication strategies (RR 1.43; 95% CI 1.22 to 1.67) and an open trial design (RR 1.37; 95% CI 1.16 to 1.63). There is no good evidence that the following strategies impact on trial response/retention: adding a non-monetary incentive (RR=1.00; 95% CI 0.98 to 1.02); offering a non-monetary incentive (RR=0.99; 95% CI 0.95 to 1.03); 'enhanced' letters (RR=1.01; 95% CI 0.97 to 1.05); monetary incentives compared with offering prize draw entry (RR=1.04; 95% CI 0.91 to 1.19); priority postal delivery (RR=1.02; 95% CI 0.95 to 1.09); behavioural motivational strategies (RR=1.08; 95% CI 0.93 to 1.24); additional reminders to participants (RR=1.03; 95% CI 0.99 to 1.06) and questionnaire question order (RR=1.00, 0.97 to 1.02). Also based on single trials, these strategies do not appear effective: a telephone survey compared with a monetary incentive plus questionnaire (RR=1.08; 95% CI 0.94 to 1.24); offering a charity donation (RR=1.02, 95% CI 0.78 to 1.32); sending sites reminders (RR=0.96; 95% CI 0.83 to 1.11); sending questionnaires early (RR=1.10; 95% CI 0.96 to 1.26); longer and clearer questionnaires (RR=1.01, 0.95 to 1.07) and participant case management by trial assistants (RR=1.00; 95% CI 0.97 to 1.04). Conclusions: Most of the trials evaluated questionnaire response rather than ways to improve participants return to site for follow-up. Monetary incentives and offers of monetary incentives increase postal and electronic questionnaire response. Some strategies need further evaluation. Application of these results would depend on trial context and follow-up procedures. [ABSTRACT FROM AUTHOR]

Objective: To explore the strategies used to improve retention in primary care randomised trials. Design: Qualitative in-depth interviews and thematic analysis. Participants: 29 UK primary care chief and principal investigators, trial managers and research nurses. Methods: In-depth face-to-face interviews. Results: Primary care researchers use incentive and communication strategies to improve retention in trials, but were unsure of their effect. Small monetary incentives were used to increase response to postal questionnaires. Non-monetary incentives were used although there was scepticism about the impact of these on retention. Nurses routinely used telephone communication to encourage participants to return for trial follow-up. Trial managers used first class post, shorter questionnaires and improved questionnaire designs with the aim of improving questionnaire response. Interviewees thought an open trial design could lead to biased results and were negative about using behavioural strategies to improve retention. There was consensus among the interviewees that effective communication and rapport with participants, participant altruism, respect for participant's time, flexibility of trial personnel and appointment schedules and trial information improve retention. Interviewees noted particular challenges with retention in mental health trials and those involving teenagers. Conclusions: The findings of this qualitative study have allowed us to reflect on research practice around retention and highlight a gap between such practice and current evidence. Interviewees describe acting from experience without evidence from the literature, which supports the use of small monetary incentives to improve the questionnaire response. No such evidence exists for non-monetary incentives or first class post, use of which may need reconsideration. An exploration of barriers and facilitators to retention in other research contexts may be justified. [ABSTRACT FROM AUTHOR]

Background Although screening and brief intervention is effective at reducing alcohol consumption in primary care and is recommended by guidelines, there are numerous barriers to its delivery. Screening newly-registered patients for alcohol-use disorders provides an opportunity for systematic collection of alcohol consumption data. Aim To examine how alcohol screening data are recorded in primary care, the extent to which they are recorded, and whether reported levels of consumption differ from general population data. Design and setting Cross-sectional analysis, with data collected from patients in the year after registration. Method Data on alcohol consumption were collected from The Health Improvement Network (THIN) primary care database from patients aged ⩾18 years, newly registered with a general practice in 2007 to 2009, and compared with the Office for National Statistics Opinions (ONS Omnibus) survey. Results A total of 292 376 (76%) of the 382 609 newlyregistered patients had entries for alcohol consumption (units a week, Read Codes for level of consumption, and/or screening test). Only 25 975 (9%) were recorded as completing a validated screening test, most commonly AUDIT/AUDIT-C (16 004, 5%) or FAST (9419, 3%). Alcohol-use disorders are underreported in primary care (for example, higher risk drinking 1% males, 0.5% females) in comparison with the Opinions survey (8% males, 7% females). Conclusion Alcohol screening data are collected from most patients within 1 year of registration with a GP practice; however, use of a validated screening test is rarely documented and alcohol-use disorders are underreported. Further efforts are needed to encourage or incentivise the use of validated tests to improve the quality of data collected. [ABSTRACT FROM AUTHOR]

This systematic review was conducted to determine the effects of self-help interactive computer-based interventions (ICBIs) for sexual health promotion. We searched 40 databases for randomized controlled trials (RCTs) of computer-based interventions, defining 'interactive' as programmes that require contributions from users to produce personally relevant material. We conducted searches and analysed data using Cochrane Collaboration methods. Results of RCTs were pooled using a randomeffects model with standardized mean differences for continuous outcomes and odds ratios (ORs) for binary outcomes, with heterogeneity assessed using the I2 statistic. We identified 15 RCTs of ICBIs (3917 participants). Comparing ICBIs to minimal interventions, there were significant effects on sexual health knowledge (standardized mean difference [SMD] 0.72, 95% confidence interval [CI] 0.27-1.18); safer sex self-efficacy (SMD 0.17, 95% CI 0.05-0.29); safer-sex intentions (SMD 0.16, 95% CI 0.02-0.30); and sexual behaviour (OR 1.75, 95% CI 1.18-2.59). ICBIs had a greater impact on sexual health knowledge than face-to-face interventions did (SMD 0.36, 95% CI 0.13-0.58). ICBIs are effective tools for learning about sexual health, and show promising effects on self-efficacy, intention and sexual behaviour. More data are needed to analyse biological outcomes and cost-effectiveness. [ABSTRACT FROM AUTHOR]

Objective: In England national clinical guidelines recommend annual screening for cardiovascular risk factors among individuals with schizophrenia and bipolar disorder within primary care supported by efforts to promote healthy behaviors by secondary psychiatric services. This study elicited the views of primary and specialty mental health care staff and service users about such service arrangements and barriers to implementation.Methods: Surveys were mailed to a representative cross-section of service users, community mental health team (CMHT) staff, and primary care staff in Western England and London.Results: Surveys were completed by 227 service users, 143 primary care staff, and 166 CMHT staff. A majority of staff stated that cardiovascular disease screening and risk reduction work were important, felt that this work was best accomplished in primary care settings, and anticipated good uptake among service users. More than 80% of service users viewed cardiovascular screening favorably, but 30% had not been screened in the past year. The proportion of service users prepared to make healthy changes in their lifestyle varied from 37% to 51%, depending on the change contemplated, but many cited difficulty traveling (35%), time pressures (28%), and a distaste for courses or group work (23%) as barriers to attending courses in healthy living.Conclusions: The obstacles to service identified by this study reinforce the importance of providing incentives for both providers and users of services to improve implementation of national clinical guidelines on mental illness. [ABSTRACT FROM AUTHOR]

Background: There are several assumptions within clinical practice about who is more or less likely to consult a health care practitioner for particular symptoms, most commonly these focus around socio-demographic characteristics. We aimed to assess the evidence for the impact of socio-demographic characteristics on consultation for back pain.Methods: We conducted a review of the literature, using systematic methods, on consultation for back pain. Using systematic searching techniques we identified peer-reviewed publications that focused on health care consultation in response to symptoms of back pain and which included data on both users and non-users of health care.Results: We identified 23 studies. Definitions of help-seeking were inconsistent across studies. The majority of the 15 studies which considered the relationship between age and help-seeking for back pain did not find evidence of an association between these two factors. Seventeen studies considered whether socio-economic position was associated with help-seeking. The evidence largely supported the conclusion of no association (13 papers). Fifteen studies included gender as a variable in their analyses, and the majority (10 papers) presented the finding of no association.Conclusions: The results from this review suggest that there is little evidence to support the common wisdom that socio-demographic characteristics impact on help-seeking in the context of back pain. As these assumptions relating to who is more or less likely to consult will ultimately affect patient care, it is important that they do not go unchallenged. [ABSTRACT FROM AUTHOR]

High experienced continuity of care in patients with cancer is associated with lower needs for care, better quality of life and better psychological outcomes. We developed and evaluated an intervention to improve experienced continuity. The intervention, consisted of (1) a 17-item patient-completed continuity assessment; (2) feedback to clinical nurse specialists and action to address the needs identified. Multidisciplinary team meetings and oncology outpatient clinics were observed, and patients and staff were interviewed. After qualitative work and reliability testing, the intervention was evaluated in a feasibility trial. Sixty-one patients provided data for analysis. No statistically significant differences were found in patients' experienced continuity between the trial arms, but important trends were seen in measures of needs for care in favour of those receiving the intervention. Feeding back findings from the continuity assessment to clinicians reduced patients' needs for care. Our results indicate that an intervention to target patients' experiences of continuity can reduce their subsequent needs for care. However, overcoming barriers to organisational change and addressing some patients' hesitation to report their continuity difficulties must be considered when implementing such an intervention. A phase III trial targeting patients with inadequate experienced continuity of care is recommended. [ABSTRACT FROM AUTHOR]

Maternal depression is associated with adverse child development, however little is known about paternal depression and child outcome. The aim of this study was to estimate the prevalence of paternal depression and assess its association with abnormal child behaviours among 4-6 year olds. Parents of 4-6 years olds were recruited via general practices and completed measures on child behaviour (Strengths and Difficulties Questionnaire), depression (Patient Health Questionnaire), and other covariates. The association of major and other paternal depressive syndrome with mother reported child behaviour was analysed. Eight percent (29/365) of fathers had depression (3.3 and 4.77% a major and other depressive syndrome, respectively). Major but not other paternal depressive syndrome was associated with an 8 and 36 times greater likelihood of child prosocial behaviour problems and peer problems respectively. [ABSTRACT FROM AUTHOR]

It is difficult to define continuity of care or study its impact on health outcomes. This study took place in three stages. In stage I we conducted qualitative research with patients, their close relatives and friends, and their key health professionals from which we derived a number of self completion statements about experienced continuity that were tested for reliability and internal consistency. A valid and reliable 18-item measure of experienced continuity was developed in stage II. In stage III we interviewed 199 patients with cancer up to five times over 12 months to ascertain whether their experiences of continuity were associated with their health needs, psychological status, quality of life, and satisfaction with care. The qualitative data revealed that experienced continuity involved receiving consistent time and attention, knowing what to expect in the future, coping between service contacts, managing family consequences, and believing nothing has been overlooked. Transitions between phases of treatment were not associated with changes in experienced continuity. However, higher experienced continuity predicted lower needs for care, after adjustment for other potential explanatory factors (standardised regression coefficients ranging from -0.12 (95% CI -0.20, -0.05) to -0.32 (95% CI -0.41, -0.23)). Higher experienced continuity may be linked to lower health care needs in the future. [ABSTRACT FROM AUTHOR]

ABSTRACT BACKGROUND: Undertreatment of depression in primary care is common. Efforts to address this tend to overlook the role of patient attitudes. Our aim was to validate and describe responses to a questionnaire about attitudes to depression and its treatment in a sample with experience of moderate and severe depressive episodes.MethodCross-sectional survey of 866 individuals with a confirmed history of an ICD-10 depressive episode in the 12 months preceding interview, recruited from 7271 consecutive general practitioner (GP) attendees in 36 general practices in England and Wales. Attitudes to and beliefs about depression were assessed using a 19-item self-report questionnaire. RESULTS: Factor analysis resulted in a three-factor solution: factor 1, depression as a disabling, permanent state; factor 2, depression as a medical condition responsive to support; and factor 3, antidepressants are addictive and ineffective. Participants who received and adhered to antidepressant medication and disclosed their depression to family and friends had significantly lower scores on factors 1 and 3 but higher scores on factor 2. CONCLUSIONS: People with moderate or severe depressive episodes have subtle and divergent views about this condition, its outcome, and appropriate help. Such beliefs should be considered in primary care as they may significantly impact on help seeking and adherence to treatment. [ABSTRACT FROM AUTHOR]

BACKGROUND: Both doctors and patients may perceive the Internet as a potential challenge to existing therapeutic relationships. Here we examine patients' views of the effect of the Internet on their relationship with doctors. METHODS: We ran 8 disease specific focus groups of between 2 and 8 respondents comprising adult patients with diabetes mellitus, ischaemic heart disease or hepatitis C. RESULTS: Data are presented on (i) the perceived benefits and (ii) limitations of the Internet in the context of the doctor-patient relationship, (iii) views on sharing information with doctors, and (iv) the potential of the Internet for the future. Information from the Internet was particularly valued in relation to experiential knowledge. CONCLUSION: Despite evidence of increasing patient activism in seeking information and the potential to challenge the position of the doctor, the accounts here do not in any way suggest a desire to disrupt the existing balance of power, or roles, in the consultation. Patients appear to see the Internet as an additional resource to support existing and valued relationships with their doctors. Doctors therefore need not feel challenged or threatened when patients bring health information from the Internet to a consultation, rather they should see it as an attempt on the part of the patient to work with the doctor and respond positively. [ABSTRACT FROM AUTHOR]

Maternal depression is associated with adverse child development, but little is known about the effects of paternal depression. This pilot study estimated the prevalence of paternal depression and mood state, and assessed the relationship between paternal mood and infant temperament. The participants in the study were 98 fathers of newborn babies. Fathers were initially screened for depressed mood (Hospital anxiety and depression scale, and Edinburgh postnatal depression scale), and at 6 months parental mood, infant temperament, couple relationship quality, alcohol use, adverse life events, parenting, and demographics were recorded. Infant fussiness was analysed in relation to paternal mood and other contextual factors using multiple regression. Of the 98 fathers, 48 (49%) completed depression-screening measures. Of these 48 fathers, 4 (8%) reported depressive symptoms above the cut-off for case definition. A total of 48% (N = 19) completed measures at follow-up. In the adjusted model, higher paternal depression scores, more traditional attitudes towards fathering, and increased recent life events were related to higher infant fussiness scores; and better couple relationship quality was related to lower fussiness scores. This study showed that 1 in 12 fathers had depressed mood, and lower mood was associated with negative infant temperament. Since the findings of this feasibility study were based on a small sample size the association of paternal mood and child development merits further study using a larger sample of fathers. [ABSTRACT FROM AUTHOR]

OBJECTIVES: to investigate the effectiveness of a pharmacy discharge plan in elderly hospitalized patients. DESIGN: randomized controlled trial. SUBJECTS AND SETTINGS: we randomized patients aged 75 years and older on four or more medicines who had been discharged from three acute general and one long-stay hospital to a pharmacy intervention or usual care. INTERVENTIONS: the hospital pharmacist developed discharge plans which gave details of medication and support required by the patient. A copy was given to the patient and to all relevant professionals and carers. This was followed by a domiciliary assessment by a community pharmacist. In the control group, patients were discharged from hospital following standard procedures that included a discharge letter to the general practitioner listing current medications. OUTCOMES: the primary outcome was re-admission to hospital within 6 months. Secondary outcomes included the number of deaths, attendance at hospital outpatient clinics and general practice and proportion of days in hospital over the follow-up period, together with patients' general well-being, satisfaction with the service and knowledge of and adherence to prescribed medication. RESULTS: we recruited 362 patients, of whom 181 were randomized to each group. We collected hospital and general practice data on at least 91 and 72% of patients respectively at each follow-up point and interviewed between 43 and 90% of the study subjects. There were no significant differences between the groups in the proportion of patients re-admitted to hospital between baseline and 3 months or 3 and 6 months. There were no significant differences in any of the secondary outcomes. CONCLUSIONS: we found no evidence to suggest that the co-ordinated hospital and community pharmacy care discharge plans in elderly patients in this study influence outcomes. [ABSTRACT FROM AUTHOR]

Much research has been done on patients' attitudes towards the use of computers in general practice consultations, but the attitudes of health professionals require further investigation. Ten out of 21 general practitioners (GPs) and eight out of 11 practice nurses were interviewed or given a written questionnaire to determine their views on the advantages and the potential uses of computers, and their impact on consultations. Professionals had expectations of improved electronic links with the local health authority and hospitals, and access to laboratory results. However, they expressed mixed views on paperless records, and concerns about patient data confidentiality and the effect of the computer on professionals' interactions with patients. All GPs and three out of 11 nurses approached were strongly opposed to the idea that computers 'dehumanize' the consultation. Primary care health professionals would benefit from computer training to have a clearer concept of the full potential of general practice computer systems, and to gain a better understanding of the issues around patient confidentiality. [ABSTRACT FROM AUTHOR]

Much research has been done on patients' attitudes towards the use of computers in general practice consultations, but the attitudes of health professionals require further investigation. Ten out of 21 general practitioners (GPs) and eight out of 11 practice nurses were interviewed or given a written questionnaire to determine their views on the advantages and the potential uses of computers, and their impact on consultations. Professionals had expectations of improved electronic links with the local health authority and hospitals, and access to laboratory results. However, they expressed mixed views on paperless records, and concerns about patient data confidentiality and the effect of the computer on professionals' interactions with patients. All GPs and three out of 11 nurses approached were strongly opposed to the idea that computers 'dehumanize' the consultation. Primary care health professionals would benefit from computer training to have a clearer concept of the full potential of general practice computer systems, and to gain a better understanding of the issues around patient confidentiality. [ABSTRACT FROM AUTHOR]

Objectives: To determine neurootological and psychiatric abnormalities associated with complaints of dizziness in an epidemiological community sample of people of working age, and the extent of comorbidity between neuro-otological and psychiatric dysfunction.Method: A survey of 3884 people randomly selected from six general practice lists identified 262 people with significant dizziness, from which a subsample of 15 men and 22 women were recruited for testing. Dizzy subjects were evaluated by blind neuro-otological testing, computerised dynamic posturography, a computerised psychiatric assessment, neuro-otological and general medical examination, and diagnosis. An age matched control group of 18 men and 22 women underwent the same evaluation.Results: Tests of auditory, vestibular, and oculo-motor function did not discriminate between dizzy subjects and controls, but dizzy subjects had significantly worse balance on posturographic testing, more diagnoses of medical disorder, and a higher prevalence of psychiatric morbidity.Conclusions: The findings suggest that dizziness in the community is typically characterised by mild physical disorder accompanied by some psychiatric disturbance. As the combination of minor physical and psychiatric disorder is known to be unusually persistent and handicapping, treatment programmes must be provided for this prevalent syndrome, perhaps by a partnership between primary care and neuro-otological and psychiatric hospital outpatient clinics with experience and expertise in the diagnosis and management of dizziness and psychiatric disturbance. [ABSTRACT FROM AUTHOR]

Background: This trial evaluated the feasibility, acceptability and effectiveness of a structured approach to the management of schizophrenia in general practice.Method: All patients with non-affective psychosis (mainly schizophrenia) in four inner-city general practices were recruited. A check-list and a set of outcome measures were used by the general practitioner and the practice nurses. Information on attendances at the general practice and psychiatric out-patient departments was also collected.Results: Two practices took part in the intervention and two served as control practices. Sixty-seven patients with non-affective psychosis were identified. Thirty-three (81%) of the 41 patients in the two intervention practices attended the initial assessment by the doctor and nurse, but only 13 (32%) attended the first review assessment. The attendance for the second review, after six months, was six out of 15 (40%) in one practice, but rose to 16 out of 18 (89%) in the other practice. Significant improvements were recorded in the intervention group on the Global Assessment Scale (GAS) and the Behaviour, Speech and Other Syndromes (BSO) subscore of the Present State Examination (PSE). The absolute risk reduction and relative risk reduction as a result of the intervention, as measured by the GAS scores, was 29% (95% CI 4% to 54%) and 36% (95% CI 5% to 66%), respectively, and in the case of the BSO subscores of the PSE, this was 23% (95% CI-1.8% to 47.2%) and 28% (95% CI-2.2% to 57%), respectively. For one patient to show an improvement in GAS and BSO scores 3.5 patients (95% CI 1.85 to 25) and 4.3 patients (95% CI-55 to 2.1), respectively, would need to receive the intervention. There was a significant increase in consultation rates for patients in the intervention practices.Conclusions: Health surveillance of patients with non-affective psychosis is possible in general practice. [ABSTRACT FROM AUTHOR]

Interactive health communication applications (IHCAs) may be particularly useful to patients and carers managing chronic disease. We have run eight focus groups with patients and two with carers involving a total of 40 participants. The focus groups were designed to seek patients' and carers' requirements of IHCAs and to identify the criteria they would use to assess them. Analysis revealed that many participants saw the value and potential of IHCAs. Even those with modest previous computer experience could use them with little tuition. The findings from this study have policy implications for the development of applications to maximize the potential benefit of IHCAs to patients and carers. [ABSTRACT FROM AUTHOR]

Background: Dizziness is commonly experienced in the community, but little is known about the long-term progression of the condition.Objective: We aimed to assess over 18 months the outcome of symptoms of dizziness in a sample of patients identified from London general practices.Method: We followed up at 18 months a cohort of patients who reported symptoms of dizziness with or without anxiety, panic reactions or avoidance of situations that provoked the symptoms. The subjects completed a structured questionnaire both at baseline and at 18 months.Results: At 18 months, 24% (95% CI = 23.5-34.8%) were more handicapped and 20% (95% CI = 15.2-25.2%) had recurrent dizziness, while 20% (95% CI = 14.9-24.8%) had improved. Patients with significant dizziness were more likely to consult their GP (OR = 14.4, 95% CI = 7.0-29.1) and were more likely to receive treatment (OR = 7.8, 95% CI = 3.2-22.4) or be referred to hospital (OR = 8.4, 95% CI = 3.2-22.4). The independent predictors of handicapping dizziness at 18 months were a history of fainting (OR = 2.4, 95% CI = 1.2-4.7), vertigo (OR = 2.6, 95% CI = 1.3-5.0) and avoidance of a situation that provoke dizziness (OR = 4.8, 95% CI = 2.5-9.0).Conclusion: Four per cent of all patients registered with a GP suffer persistent symptoms of dizziness and at least 3% are severely incapacitated by their symptoms. The presence of vertigo, fainting and avoidance in a person with dizziness is predictive of chronic handicapping dizziness. Further research is required on the progressions of symptoms of dizziness in a sample of GP attenders and those in the community. [ABSTRACT FROM AUTHOR]